I reviewed the August 13, 2002 submission for National Genome Testing Lab (NGTL) Automation System (NAS), version 5.2.0, BK020032. The submission was a traditional 510(k). It consisted of two volumes. This software device has been used by ARC for [-----------------------------------].

Intended Use:

The intended use is stated to be data management software that is not intended to perform any interpretations of test results, but rather to assemble and correlate automated and/or manual test results by unique identification number from blood samples. NAS blood testing information can include information pertinent to collections, sample/pool tracking, results management, administration, reporting, and test process turnaround statistics.

Hardware and Software Platform:

NAS is based on client server architecture. The NAS servers include the application server components that are used at the National Headquarters Data Center and the Disaster Recovery Data Center. NAS applications run on IBM RISC System 6000 servers connected to an EMC2 disk storage array running the AIX 4.3.2 operating system. User sites of NAS operating on Windows 95 and Windows NT are connected via their Local Area Networks (LAN's) to a Wide Area Network (WAN). The end user devices are PC workstations. Several manufacturers meet ARC desktop requirements. Standard PC desktop requirements are:

Review of the August 9, 2002 submission required additional information from the sponsor before a recommendation could be made. The sponsor provided the additional information in a February 7, 2003 response. FDA had a telecon with ARC on March 7, 2003 requesting clarification of their response. This information was provided in faxes received March 7 -12, 2003. The firm will follow-up with hardcopies.